FDA Inspection
Patheon Manufacturing Services LLCPatheon Manufacturing Services LLC – FDA Inspection, May 24, 2024
Record Details
This FDA Inspection record concerns Patheon Manufacturing Services LLC, with an inspection on May 24, 2024, issued by the Atlanta District Office, covering human drugs.
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ID · e0acc1e8-8d7a-4c45-9831-9cef9c79d9e5
Inspection Facts
- Inspection number
- 1238532
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Patheon Manufacturing Services LLC
17| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | NAI | Atlanta District Office | Drug Quality Assurance |
| November 27, 2024 | Not classified | Atlanta District Office | |
| February 23, 2024 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 4, 2022 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 17, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Patheon Manufacturing Services LLC
- FDA Inspection 1270187 - 2025-09-26
- FDA Inspection 1257333 - 2024-11-27
- FDA Inspection 1229060 - 2024-02-23
- FDA Inspection 1176425 - 2022-08-04
- FDA Inspection 1096860 - 2019-05-17
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